Sirius Femoral Stem, Size 30A— 510(k) K142295

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K142295 for Sirius Femoral Stem, Size 30A, Substantially Equivalent on 2014-09-15. Applicant: Biomet, Inc..

Clearance details

Applicant: Biomet, Inc.
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 2014-08-18
Decision date: 2014-09-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDI

product code JDI

Death: 65
Injury: 12,943
Malfunction: 1,681
Total: 14,689

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.